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FDA 510(k)

BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter

K-Number: K231653 · 2023-07-03

ApplicantThrombolex, Inc.
Decision Date2023-07-03
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter is a medical device manufactured by Thrombolex, Inc.. It received FDA 510(k) clearance on 2023-07-03 under approval number K231653. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter?

BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter is a medical device that received FDA 510(k) clearance on 2023-07-03. It is manufactured by Thrombolex, Inc.. The 510(k) number is K231653.

When was BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter approved by the FDA?

BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter received FDA 510(k) clearance on 2023-07-03, under approval number K231653.

What company makes BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter?

BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter is manufactured by Thrombolex, Inc..

What is the FDA product code for BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter?

The FDA product code for BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter is QEY.

Related Clinical Trials

NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT06588543 Patient-specific Planning of Minimally Invasive Brain Interventions Based on Vascular-hemodynamic Mapping RECRUITING NCT04790370 Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism ACTIVE_NOT_RECRUITING NCT07542938 Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis NOT_YET_RECRUITING

Other Devices by Thrombolex, Inc.

K193071Bashir Plus Endovascular Catheter K192598Bashir S-B Endovascular Catheter, Ref. No. 7101 K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240) K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101

Related Devices (Code: QEY)

K162777Squirt Fluid Delivery SystemMerit Medical Systems, Inc. K153488Occlusion Perfusion CatheterAdvanced Catheter Therapies, Inc. K163356Pulse* Spray Infusion System, Uni*Fuse Infusion SystemAngioDynamics, Inc. K162771EkoSonic Endovascular System with Control Unit 4.0Btg International, Inc. K170258SpeedLyser Infusion Catheter KitAngioDynamics, Inc. K182324EkoSonic Endovascular SystemBtg International, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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